Description:

Leetrexate Methotrexate Injection IP 50mg/2ml is a sterile solution of methotrexate, a folate antagonist antimetabolite. It is used in high-dose regimens for certain cancers (e.g., acute lymphoblastic leukaemia, non-Hodgkin’s lymphoma, breast cancer, osteosarcoma, choriocarcinoma), as well as lower-dose treatment for severe rheumatoid arthritis, severe psoriasis, and other autoimmune/inflammatory conditions when other therapies fail or are intolerable. Methotrexate inhibits dihydrofolate reductase, interfering with DNA/RNA synthesis and cell proliferation, particularly in rapidly dividing cells.

Prescription: Prescription-only (Rx). Administered only by healthcare professionals (intramuscular, intravenous, intra-arterial, or intrathecal); requires specialist oversight (oncologist, rheumatologist, dermatologist) due to high toxicity, need for monitoring (blood counts, liver/renal function), and potential need for folinic acid (leucovorin) rescue in high-dose therapy.

Therapeutic Category:

Antineoplastic / Antimetabolite / Immunosuppressant (folate antagonist for oncology and autoimmune diseases).

Active Ingredients/Composition:

Each 2 ml vial contains: Methotrexate sodium equivalent to methotrexate 50 mg (25 mg/ml). Excipients: Sodium chloride (for isotonicity), sodium hydroxide/hydrochloric acid (pH adjustment), water for injection (sterile, preservative-free solution in single-dose vials).

Vitamins: None.

Minerals: None.

Variant: 50 mg/2 ml (25 mg/ml) injection in single-dose vial (standard strength for IM/IV use; higher concentrations or multi-dose vials exist in other brands, but this is common for oncology/rheumatology).

Consume Type:

Parenteral (injection: intramuscular, intravenous push/slow infusion, intra-arterial, or intrathecal; never oral—oral methotrexate exists separately).

Directions/Usage: Administered only by trained professionals with monitoring (CBC, liver/renal function, hydration).

• Oncology (high-dose): 50 mg/m² to several g/m² IV with leucovorin rescue, hydration, and urine alkalinisation.
• Rheumatoid arthritis/psoriasis (low-dose): 7.5-25 mg IM/IV/SC once weekly (often 15-25 mg/week).
• Other: Dose varies by indication/weight (e.g., 50 mg single dose or divided). Frequency: Weekly for autoimmune; intensive cycles for cancer. Use lowest effective dose; monitor for toxicity. Not self-administered.

Common Side Effects:

• Gastrointestinal: Nausea, vomiting, stomatitis/mucositis, diarrhoea, anorexia
• Hematologic: Bone marrow suppression (leukopenia, thrombocytopenia, anaemia)
• Hepatic: Elevated liver enzymes, hepatotoxicity
• Other: Fatigue, alopecia (hair loss), skin rash, photosensitivity
• Injection site reactions (pain, redness) Serious: Pulmonary toxicity (interstitial pneumonitis), severe hepatotoxicity, neurotoxicity (intrathecal), opportunistic infections, tumor lysis syndrome. Seek immediate help for mouth sores, fever, bleeding, shortness of breath, or jaundice.

Package Type:

Single-dose glass vial of 2 ml (containing 50 mg methotrexate; sterile; often in individual carton or box with instructions).

Storage Advice: Store at room temperature (15-30°C), protected from light. Do not freeze. Keep in original packaging. Use immediately after opening; discard unused portion. Keep out of reach of children.

Safety Advice:

• High toxicity—use only under specialist supervision with regular blood tests (CBC weekly initially, liver/renal function).
• Contraindicated in severe renal/hepatic impairment, active infection, pregnancy (Category X—teratogenic), breastfeeding, or known hypersensitivity.
• Risk of severe bone marrow suppression, hepatotoxicity, pulmonary toxicity—monitor closely.
• High-dose requires leucovorin rescue, hydration, urine alkalinisation to prevent nephrotoxicity.
• Avoid live vaccines, alcohol (liver risk), NSAIDs (increased toxicity).
• Pregnancy: Contraindicated (fetal harm); effective contraception required during/after treatment.
• Report any mouth sores, fever, unusual bleeding, cough/shortness of breath, or yellowing skin promptly.
• Not for routine use—reserved for severe conditions.

Product Substitutes: Other methotrexate 50mg/2ml injections in Ghana: Generic methotrexate (various importers), Methotrexate Injection IP (from Cipla, Sun Pharma, or local brands). Alternatives: Oral methotrexate tablets (for low-dose autoimmune use), or other DMARDs (e.g., methotrexate alternatives like leflunomide, sulfasalazine) or biologics for rheumatoid arthritis/psoriasis. Consult rheumatologist/oncologist for equivalents.

Manufacturer/Marketer:

John Lee Pharmaceuticals Pvt. Ltd.

Country of Origin:

India.